While a medical device company’s product might be its largest focus (namely development and manufacturing), its Quality Management System should be the company’s backbone or foundation. Without a solid one, the company is at risk of, at worst, producing unsafe product or, at best, incurring costly mistakes and inefficiencies.
Whether new or established, Kapstone can help companies of any size develop, implement, maintain, and improve their QMS for every global market. Our consultants have collectively been in dozens of audits over decades of experience and know how to chart the best course of action for a particular company. Kapstone is best positioned to advise and execute on your QMS needs.
Templates for a Quality Management System
With decades of experience in the medical device industry successfully launching dozens of products in various regions around the globe and going through countless audits, we are confident about our expertise and knowledge of the procedures appropriate for virtually any company.
We can provide templates for a QMS that greatly improve the speed to readiness and decrease the labor cost compared to starting from scratch.
Your Quality System should be customized depending on a variety of factors.
- In which market(s) are you selling product?
- Does your product have software? Are you developing the software (e.g. SaMD)?
- Do you have an electronic or paper based system?
- Are you (or intend to be) ISO13485-certified?
- What is the level of risk of your products?
- Which role(s) in the commercialization process are you taking (e.g. developing, manufacturing, packaging, selling/distributing, etc.)
The Kapstone QMS is segmented into the following modules to make it easy for new companies to acquire sections as they need:
- Lean Starter
- Starter
- Production
- Software Development
- EU MDR
- MDSAP (various regions)
- Electronic Records
Contact us to learn more.
The Kapstone QMS includes SOPs (Standard Operating Procedures), a Quality Manual (or Policy), Forms, Logs, and Work Instructions. It is offered in versions compatible with a paper-based system or on an electronic QMS software platform.
Choosing the Right Quality Management System: Paper vs. Electronic
While many medical device companies are switching to electronic quality management systems (eQMS), there are also some benefits to preserving a traditional “paper-based” system if you have one. We can help you decide whether it’s best to keep your current system, transition to an eQMS, or even use a combination.
Some of the benefits of going electronic include:
- Consolidation of all records and documentation into one accessible system
- Automatic version control
- Fully transparent for both internal and external stakeholders
- Easy integration with other technology systems
Learn more about eQMS and how Kapstone can help you implement this type of system.
-1.png)
